BEUDAMED
    FDA Recall Terminated

    Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

    Recall: Z-0427-2014 · Initiated October 16, 2013

    Recall

    Recall Number
    Z-0427-2014
    Event Number
    66674
    Firm
    Cutera, Inc.
    FEI Number
    3002900199
    Product Code
    OPT
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 16, 2013
    Posted
    December 9, 2013
    Terminated
    December 9, 2013
    Address
    3240 Bayshore Blvd, Brisbane, CA, 94005-1021

    Description

    Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

    Reason

    Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. Both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin.

    Action

    Cutera sent an IMPORTANT SAFETY INFORMATION letter dated October 16, 2013, to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. It is important that you share this correspondence and the updated Operator Manual andvtreatment guidelines with all staff at your office that use the truSculpt, so they are aware of this new safety information. Please immediately remove and dispose of the current truSculpt Operator Manual and clinical guidelines and replace them with the new and revised truSculpt Operator Manual and clinical guidelines. Customers with questions were instructed to call 415-657-5500 or 415-657-5568.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Canada

    Quantity

    451